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Data / Medical devices / Automated External Defibrillators (Non-Wearable) / United States

FDA-registered makers of Automated External Defibrillators (Non-Wearable) in the United States: 25 establishments

25 establishments in the United States are registered with the FDA to make Automated External Defibrillators (Non-Wearable) (product code MKJ). 17 have a 510(k) clearance or PMA approval on file and 8 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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Device
Automated External Defibrillators (Non-Wearable)
Product code
MKJ
Country
United States

Makers of Automated External Defibrillators (Non-Wearable) in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Zoll Medical CorporationChelmsford, MA, United StatesComplaint file establishment, Manufacturer, Specification developer4March 21, 20124120api.fda.gov
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Manufacturer6May 28, 2002131api.fda.gov
Conmed CorporationWestborough, MA, United StatesSpecification developer6May 28, 2002100api.fda.gov
Physio-Control, Inc.Redmond, WA, United StatesComplaint file establishment, Manufacturer, Specification developer1December 19, 20144515api.fda.gov
Amco International Manufacturing & Design, Inc.Brooklyn, NY, United StatesManufacturer4August 7, 2009000api.fda.gov
Philips North America LLCBothell, WA, United StatesManufacturer, Specification developer2December 17, 19982200api.fda.gov
Philips North America LLCWoodinville, WA, United StatesManufacturer, Specification developer2December 17, 1998200api.fda.gov
AED Battery Exchange, LLCWauconda, IL, United StatesRemanufacturer1November 1, 2012100api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer1May 12, 1998100api.fda.gov
Avive Solutions IncBrisbane, CA, United StatesSpecification developer0100api.fda.gov
Cardinal HealthChicopee, MA, United StatesContract manufacturer, Manufacturer, Manufacturer for export0100api.fda.gov
Defibtech, LLCGuilford, CT, United StatesSpecification developer0180api.fda.gov
Defibtech BranfordBranford, CT, United StatesManufacturer0100api.fda.gov
Defibtech North BranfordNorth Branford, CT, United StatesManufacturer0100api.fda.gov
Graphic Controls Acquisition Corp.dba Nissha Medical TechnologiesBuffalo, NY, United StatesComplaint file establishment, Manufacturer for export, Specification developer0111api.fda.gov
R & D Batteries, Inc.Burnsville, MN, United StatesManufacturer1December 8, 2014000api.fda.gov
TZ Medical, Inc.Tualatin, OR, United StatesSpecification developer0100api.fda.gov
Ansen CorporationOgd, NY, United StatesContract manufacturer0000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
Caf Medical Solutions IncHockley, TX, United StatesManufacturer for export0000api.fda.gov
ItechSan Diego, CA, United StatesContract manufacturer0000api.fda.gov
Katecho LLCDes Moines, IA, United StatesContract manufacturer0000api.fda.gov
Tecan Cdmo Solutions MH, Corp.Morgan Hill, CA, United StatesContract manufacturer0000api.fda.gov
ZOLL Medical CorporationPawtucket, RI, United StatesContract manufacturer0030api.fda.gov
ZOLL Medical CorporationDeerfield, WI, United StatesContract manufacturer00190api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.